STUDY: Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway (The PATHWAY study)

You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully. Talk to others about the study if you wish. • Part 1 tells you the purpose of the study and what will happen if you take part.• Part 2 gives you more detailed information about the process of the study. Please ask us if there is anything that is not clear or if you would like more information.

Part 1

1.1 What is the purpose of the study?You will be involved in a research study designed to see whether it might be helpful to include a psychological therapy alongside the usual cardiac rehabilitation pathway for patients experiencing distress following a cardiac event. Following medical treatment some people on the cardiac rehabilitation pathway experience difficulties with anxiety, low mood, upsetting memories or thoughts. The purpose of this study is to find out whether a psychological therapy called metacognitive therapy (MCT) delivered in a small group is useful in helping people to manage more effectively following a cardiac event. Specifically, the study will compare the usual treatment along the cardiac rehabilitation pathway with the usual treatment plus group metacognitive therapy.

1.2 What is the therapy?Group Metacognitive Therapy Metacognitive therapy is a psychological therapy that helps people to manage worries, low mood and distressing thoughts and feelings. Metacognitive therapy helps people to discover new and more helpful ways to react to negative or distressing thoughts, so that they are less likely to dwell on them, with a positive effect on anxiety and mood. Patients who choose to participate in this study will be asked to attend 6 group metacognitive therapy sessions. A trained health professional will deliver the therapy which aims to enable patients to more effectively manage any difficulties. Although the group metacognitive therapy sessions will be provided in small groups, you will not be expected to talk about anything that you would like to remain confidential. Participating in the group metacognitive therapy sessions will not affect your current or future healthcare.

1.3 Why have I been invited? You have been invited to take part in this study because you have been referred to the cardiac rehabilitation pathway and have indicated that you might be experiencing some distress/difficulties.

1.4 Do I have to take part? No – it is your decision entirely and taking part is voluntary. If you do decide to take part, you will be given this information sheet to keep and will be asked to sign a consent form which acknowledges you have fully understood what you are taking part in. If you do consent, you are still free to withdraw from the study at any time. You do not need to give a reason. Withdrawing from the study will not affect your current or future healthcare.

1.5 What will happen if I take part?

Group metacognitive therapy sessions

• If you agree to take part, you will be randomly allocated to either: o (1) 6 group metacognitive therapy sessions in addition to your usual care along the cardiac rehabilitation pathway oro (2) Your usual care along the cardiac rehabilitation pathway with NO group metacognitive therapy sessions.• If you are allocated to the group metacognitive therapy you will receive 6 sessions of treatment (as described above). The sessions will be weekly and each one might last up to an hour. Each session will take place at your local hospital.

Random allocation is similar to the 50/50 chance of getting heads vs. tails when a coin is tossed. Therefore we will not be able to tell you which group you are likely to be assigned to before you agree to take part. The random allocation will be carried out by an independent service using a computer programme (The Manchester Academic Health Science Centre Clinical Trials Co-ordination Unit – MAHSC CTU) to ensure it is completed in a fair and unbiased manner.

1.6 Audio-recording of the group metacognitive sessions

As part of our aim to improve the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway, audio-recording the group metacognitive sessions is important to make sure that the therapy you are receiving is being delivered as expected. Also, the audio-recordings will help to provide further support to the staff delivering the therapy.

The audio-recordings of group metacognitive sessions will be transcribed and any information which identified you (e.g., name) will be anonymised and all information kept confidentially.

Questionnaires

• You will be asked to complete some questionnaires before the start of the study which will take about 20 minutes to complete. These will be repeated at 4 months and 12 months after the start of the study. Patients taking part in the group metacognitive therapy will also be asked to complete one questionnaire at the end of each therapy session which will take approximately 5 minutes to complete.

Interviews• You will also be asked whether you would like to participate in interviews to find out about how being a cardiac rehabilitation patient has affected you, and about your experiences of clinical care and of metacognitive therapy. A member of the research team will contact you separately about this part of the research.• The interviews will be conducted by a member of the research team who is not involved in providing treatment and at a time and place that is convenient for you. Interviews can be conducted at your home, at the Rawnsley Building (Manchester Royal Infirmary), the hospital where you received cardiac rehabilitation treatment (facilities permitting) or over the telephone, or some other suitable venue of your choice.• There is no obligation to take part in interviews and if you chose not to do so this will not affect your participation in the rest of the study.• The information that we gather from interviews will be used to help us to assess whether metacognitive therapy is effective in helping patients to cope more effectively with distressing thoughts and feelings.

1.7 What about confidentiality? Relevant sections of your medical notes and data collected during the study may be looked at by individuals from the University of Manchester, from Greater Manchester Manchester Mental Health Foundation Trust (GMMH), relevant staff at the hospital where you are receiving cardiac treatment and The MAHSC CTU where it is relevant to your taking part in this research. Questionnaire data will be anonymised and pseudonyms used in interview data. If you consent, your name and date of birth will be sent to the Health and Social Care Information Centre (HSCIC). In the event of your death the HSCIC will then supply the research team with the date of death on behalf of the Office for National Statistics. All data we obtain will be securely stored for 15 years in accordance with NHS policy.

All information collected during this study will be kept confidential in accordance with NHS Data Protection guidelines. Identifying information will be anonymised. Confidentiality will only be breached if you disclose to us information which may indicate harm to yourself or others. We will take every opportunity to discuss any possible breaches of confidentiality with you prior to informing any appropriate agencies e.g. cardiac service staff, GP or A&E services.

1.8 What are the possible benefits of taking part?

The information we gather from this study will help to inform care on the cardiac rehabilitation pathway for future patients.The group metacognitive therapy sessions are designed to aid you in managing distress so you may benefit from receiving this therapy.

1.9 What are the possible risks of taking part? It is possible that talking about your difficulties may cause some distress. However, the group metacognitive therapy sessions are designed to aid you in managing your feelings more effectively.

It is important to understand that only half of the patients recruited to this study will receive the group metacognitive therapy sessions. The other half will receive care along the cardiac rehabilitation pathway as usual. This will be allocated completely at random, and therefore we are unable to tell you which group you will be assigned to prior to you agreeing to take part.

2.0 Are you participating in any other research?

Please inform the researchers and cardiac staff if you are currently participating in any other research so this can be discussed further.

2.1 What if there is a problem?Any complaint about the way you have been dealt with during this study or any possible harm you might suffer will be addressed. Further information on this is given in part 2.

Thank you for reading Part 1 of this Information Sheet. If the information in Part 1 has interested you and you are considering participation, please continue to read the additional information in Part 2 before making any decision.

Part 2

2.2 What will happen if I don’t want to carry on with the study? You are free to withdraw from the study at any point. In the event that you withdraw from the study, all data obtained up until the point of withdrawal will be kept and analysed. However, all information we have collected from you can be destroyed if you wish by contacting a member of the research team. If you withdraw from the study, it will not affect your usual care in any way.

2.3 What if there is a problem or I have a complaint about the study?If you have a concern about any aspect of this study, you should speak to the researchers who will do their best to answer your questions (see contact details on page 3). If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure. Details of this procedure can be obtained from your hospital site.

This study is covered by the NHS indemnity for harm due to negligence and non-negligence. In the event that something goes wrong and you are harmed during the study then you may have grounds for legal action against the NHS, but you may have to pay your legal costs. The normal NHS complaints mechanisms is also be available to you.

2.4 Will I be compensated for my participation in the study?

You will receive reasonable reimbursement for any travel or parking expenses that you incur as a result of your participation in the study and attending the group metacognitive therapy.

You will receive a small payment/shopping voucher for completing the questionnaires.

2.5 How will the data collected about me be stored and used? All data collected for this study will be kept safely and securely on computer and on paper records for 15 years. Clinical notes will be kept in your patient file at >>INSERT NAME OF HOSPITAL SITE<< in accordance with NHS policy. Professor Adrian Wells, who is the Chief Investigator for this study, will be the custodian of all study data. All details that could identify you will be removed from the typed records of interviews and questionnaires before these are analysed by the study team. The results will be published in reports and scientific journals, but it will not be possible to identify any individuals from these reports. The study team will send you a summary of the results at the end of the study if you would like one.

2.6 Who is organising and funding the study?The study is funded by a National Institute for Health Research programme grant. Greater Manchester Mental Health Foundation Trust (GMMH) are sponsoring and organising the study.

2.7 Who has reviewed the study?All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee to protect your safety, rights, wellbeing and dignity. This study was reviewed and given a favourable ethical opinion for conduct in the NHS by NRES Committee North West - Preston [Ref number: 15/NW/0163]. The study has also been reviewed by experts in the field of heart disease and psychology.

NIHR disclaimer: This website presents independent research commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (RP-PG-1211-20011). The views expressed in this website are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.